(63 days)
This product is intended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive oscotomy and segment are indicated. This includes conditions such as, syndromic cramosynostosis, midfacial cetrusion, hemifacial microsomia, und mandibular micrognathia. The device is mended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones
This device is a distraction system consisting of the following major components; distractor frame, plates, machine screws, flexible shaft, and distraction key. The plates and frame initially stabilize and then gradually distract the osteotomy. The flexible shaft, covered with a protective sheath, is connected to the frame and provides the point of attachment for the key used to initiate the distraction of the osteotomy.
The Cohen Distractor is a bone distraction system intended for use in the treatment of cranial, midfacial, or mandibular conditions requiring reconstructive osteotomy and segment advancement. These conditions include syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular micrognathia. The device's purpose is to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones.
The provided text focuses on the device's mechanical performance rather than clinical efficacy studies. Therefore, acceptance criteria and performance are reported for mechanical characteristics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance (Cohen Distractor) |
|---|---|
| Frame Stiffness (compared to predicate devices) | Significantly greater than MULTI-GUIDE™ and Vazquez-Diner devices |
| Average Yield Strength (compared to predicate devices) | Significantly greater than MULTI-GUIDE™ device; Slightly lower than Vazquez-Diner device |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The number of Cohen Distractor units, Vazquez-Diner Distractor units, and MULTI-GUIDE™ distractor units tested for static cantilever bend testing is not explicitly stated. The text only mentions "the Cohen Distractor and two currently available and legally marketed distraction devices."
- Data Provenance: The data is from mechanical testing conducted as part of the 510(k) submission process. This is a controlled engineering study, not
clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this study is based on objective measurements from static cantilever bend testing, not expert interpretation or consensus of clinical data. The mechanical properties are physical characteristics.
4. Adjudication method for the test set:
- Not applicable. This was a mechanical engineering study, not an evaluation of clinical outcomes requiring adjudication. The results would be quantitative measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This was a pre-market submission for a physical medical device (bone distractor), not an AI-powered diagnostic or imaging device. Therefore, no MRMC study or AI-related effectiveness analysis was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. As stated above, this device is a bone distractor, not an algorithm or AI system.
7. The type of ground truth used:
- The "ground truth" here is the objective measurement of mechanical properties (frame stiffness and yield strength) obtained through controlled laboratory testing (static cantilever bend testing) on the devices.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not a machine learning algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.